TraceGains Inc.

TraceGains FDA Audit Checklist Prepares Food Manufacturers for Inspection Day

TraceGains FDA Audit Checklist Prepares Food Manufacturers for Inspection Day


Westminster, CO -- (SBWIRE) -- 02/10/2014 -- TraceGains, a web-based compliance and regulatory document management solution for the food and beverage industries has prepared an audit checklist to help food and beverage manufacturers prepare for FDA Audit Inspections. The FDA Audit Inspection Day Checklist will help alleviate some of the stress and worry by giving information needed to prepare for the next FDA Audit Inspection.

The multiple-step audit includes information regarding how to greet the FDA auditor and begin notifications of the auditor’s arrival. The audit checklist also includes helpful notations to managers. For example, it is perfectly acceptable to ask the FDA auditor if there is any particular reason for the inspection. They may not reveal the reason. Sometimes they are not permitted to tell the reason for the inspection, while other times they are. In either case it is perfectly acceptable for business leaders to ask.

The checklist includes information about rights regarding to requests for records. Required records must be handed over to the FDA upon request. Businesses must provide copies of product labeling if the FDA requests. Most of the records such as manufacturing records or inventory are only required when the FDA identifies a reasonable risk to consumer safety, specifically, the FDA has a reasonable basis to believe that the product is adulterated and that it presents a serious threat of adverse consequences or death. If the FDA has made the determination that that is the case, industry leaders are obligated to provide those. There will likely be a final meeting to close out the inspection.

About TraceGains, Inc.
TraceGains ( provides food and beverage manufacturers and distributors with a web-based, full-service supplier, compliance, and regulatory document management solution that automates and streamlines processes to convert static documents into actionable data. With a network of more than 5,000 supplier members and more than 250 deployment sites, TraceGains offers an ever-expanding database of suppliers, purchased items, and documents that companies can leverage to improve product quality, accelerate product development, and meet regulatory and audit pressures. TraceGains not only digitizes all incoming documents, making them easily searchable, but also extracts critical data and analyzes them against customer-specific business and compliance rules, alerting stakeholders to any non-compliance. TraceGains’ automated solution assures companies that documentation is up to date, organized, and searchable, making companies 365 Audit Ready. TraceGains’ customers boast a four to six month return on their investment. Recently, TraceGains was listed as one of Food Logistics Top 100 software and technology providers. Follow TraceGains on Twitter at @tracegains.

TraceGains, Inc.
Jennifer Brusco
Marketing Strategist